Boston Scientific is conducting a Recall on CircuCool¿ Tubing Sets used with the Chilli II¿ Cooled Ablation System because there may be a potential for a sterile barrier breach which could compromise device sterility and potentially the sterile field. Even though there have been no reported complaints.

FDA DeterminedCause 2

PRODUCTION CONTROLS: Packaging

Action

Boston Scientific Corporation sent an Urgent Medical Device Recall letter, dated September 27, 2010, to all customers via overnight Federal Express. The letter described the product, the problem, and the action the customer should take. The letter instructed customers to cease distribution of affected devices and remove them from their inventory, segregate in a secure location for return to Boston Scientific. A Reply Verification Tracking Form was to be completed and returned via email or faxed to (510) 624-2475 even if the customer did not have any of the affected product.
If affected units were located the customer was to call (510) 624-2563 to obtain a Returned Good Authorization (RGA) Number and return to:
Boston Scientific Corporation
US Distribution Center
Boston Scientific Marina Bay
Customer Fulfillment Center
500 Commander Shea Blvd.
Quincy, Massachusetts 02171
RGA: _________________
For additional questions call (510) 624-2563.